EU regulatory experts explain the Unique Device Identification (UDI) system and what it means for you under EU Medical Device Regulations 2017/745 and 2017/746.
News
IFRA 49th Amendment coming soon!
A 49th update to the International Fragrance Association's self-regulatory system is expected at the end of 2019. Keep updated on new standards for cosmetics.
EU – USA Cooperation in Medical Devices
Europe and US set to work together to reduce barriers and increase trade in medical products. Cooperation could reduce manufacturing costs and improve controls.
Upcoming event: RMD + CRCC 2019 in Brussels
Obelis invites you to its 4th ERPA Annual Congress on Regulations and Compliance for Cosmetics and EAAR Annual MDR Conference on October 28-29, 2019.
Request to SCHEER for a scientific opinion on the safety of breast implants in relation to anaplastic large cell lymphoma
SCHEER called to release scientific opinion on safety of breast implants in relation to anaplastic large cell lymphoma (BIA-ALCL) in Europe.
European Commission Expert Panels on Medical Devices and In Vitro Diagnostic Devices
The European Commission called for the creation of expert panels to advise and support on new EU medical device and in-vitro device regulations.
MDR Update: Notified Body designations and first MDR CE Certificate
European Commission announce first four notified body designations and first CE certificate awarded under Medical Device Regulation 2017/745/EU.
UK Government publishes EU Exit Regulation for Medical Devices
UK government prepares for Brexit with new UK Medical Device Regulation based on retained EU law. It includes the definition of the new UK Responsible Person.
Scientific Opinion on the use of AVO in cosmetic products
SCCS issues scientific opinion on the use of acetylated vetiver oil in EU cosmetic products. Concludes AVO unlikely to cause contact allergies in humans.
Zinc Pyrithione under review by SCCS
Scientific Committee on Consumer Safety (SCCS) review zinc pyrithione as a safe ingredient in EU cosmetics under regulation 1223/2009. Results due October 2019.